Webinar 27th Nov: The future of medtech. Learn more.
Our proven experts guide you through medical device CE certification. You gain hands-on support in regulatory affairs and quality management, ensuring regulatory compliance. Plus, as a Swiss Authorised Representative, we facilitate your access to the medical device market in Switzerland.
Decomplix becomes your professional compliance partner. We guide you to your CE mark and ensure your compliant quality management. You get expert advice on how to overcome key regulatory hurdles on the way to getting your product to market.
More about our CE mark servicesTransform your algorithm into a CE-certified medical device software in less than a year. Decomplix, with its partner platform Evidencio, can offer a fast, proven, de-risked solution.
More about our medical device software serviceAs your Swiss Authorised Representative (CH-REP), we ensure your market access in Switzerland. Our high level of compliance and regulatory knowledge was confirmed with a Swissmedic inspection with no non-conformities in April 2022.
More about our CH-REP serviceWe offer consulting, training and ready-to-use templates for procedures, checklists and other tools for the compliant import of medical devices into Switzerland. Our proven experts tailor the processes together with you to your needs for fixed price.
More about our importers serviceIn 2025, Swissmedic will inspect Swiss importers of medical devices for compliance with the MedDO and IvDO. Our experts will prepare you efficiently for the inspection so that you do not risk any interruption to your business.
More about our inspection readiness check100+ medical device and in-vitro diagnostic companies of all shapes and sizes trust Decomplix — from startups to corporates, from Switzerland to all around the globe.
Read more about us«Decomplix gives us the necessary security in the use of software as a medical device during digitalization.»
«Being a German high-quality manufacturer for medical devices with more than 110 years of experience and operating worldwide, we feel very safe with Decomplix.»
«Due to service quality, regulatory knowledge, and reliability, we can highly recommend Decomplix as CH-REP.»
«We benefited tremendously from Decomplix's experience and expertise in working with the Swiss authority, Swissmedic, and with Notified Bodies.»
«With Decomplix as our CH-REP and partner, we feel well-supported. The collaboration is exceptionally professional and efficient.»
«We are very satisfied with the support and helpful knowledge of Decomplix as CH-REP.»
«It feels very good to have Decomplix as CH-REP.»
«Decomplix offers a professional approach and streamlined process for compliance and specific requirements of the Swiss market.»
«We appreciate the clear procedure, the professional approach, and the uncomplicated cooperation and highly recommend Decomplix as a business partner.»
«With the regulatory evaluation of our planning software, we were able to take key steps in product development with Decomplix.»
«As a premium manufacturer of ophthalmic instruments, we feel very secure with Decomplix.»
«Decomplix as CH-REP is our partner of choice, providing us with a great comprehensive service and allowing us to focus our internal resources on other projects.»
«Decomplix has done an excellent job for the SwissCovid App while working under high pressure. The team is reliable, fast and extremely competent.»
«For our digital health initiatives, we feel we are in safe hands with Decomplix.»
«Thanks to Decomplix' great expertise, pragmatic approach and support, we were ready for the CH requirements for IVD/MD importers and CH-REPs within a short time.»
«Decomplix quickly provides us with new and updated information on medical devices in Switzerland. We are very satisfied with their service.»
«Decomplix' Regulatory Support helps us quick and uncomplicated — I can thoroughly recommend it to any medical start-up.»
«Decomplix took a pragmatic approach and enabled us to make an informed decision on the regulatory pathway.»
«Decomplix provided valuable expertise for understanding the regulatory framework of medical device, data protection and IT security.»
«Thanks to the comprehensive strategy workshop with Decomplix, we understand how to classify and develop our product Rikai as medical device software.»
«The flexibility, broad-based expertise and the will to always find a suitable solution for our problems as a small MedTech company are qualities we greatly appreciate about Decomplix.»
Swissmedic
Swissmedic has published version 1.1 of the Information Sheet on Systems and Procedure Packs (SPP), featuring minor editorial changes and the addition of a notable example in Chapter 4.1: specimen collection kits are considered Procedure Packs.Â
Swissmedic’s position is misaligned with the note in chapter 2.6.1 of MDCG 2024-11 on the qualification of in-vitro diagnostic devices (IVD), which indicates that the qualification as either a Procedure Pack, according to the MDR, or an IVD Kit, according to the IVDR, should be based on the intended purpose of the whole product combination and that a Procedure Pack should not have an intended purpose that corresponds to Article 2(2) IVDR.
Moreover, Swissmedic’s position is also different from MDCG 2020-16 rev.4 on the classification of IVDs which considers kits intended for specimen collection by lay persons to be Class A IVDs, per rule 5(c).
This unfortunate position from Swissmedic may result in the diverging regulatory status of a same specimen collection kit in Switzerland and in the EU.
MedTech Europe
Medtech Europe has published a joint position paper on Digital label for authorised representative and importer, which urges the European Commission to allow details regarding the EU Authorised Representative and EU importer to be provided digitally, rather than solely on the physical label.
European Commission
The last amendment to the official list of Harmonised Standards (i.e. Implementing Decision (EU) 2025/2078 of 17 October 2025) only introduced standards relative to surgical clothing and drapes, medical face masks, and low temperature steam and formaldehyde sterilizers. It is however important to be aware that a new Consolidated List of HS under the EU MDR is now available.
Swissmedic
The information sheet for the cosmetic sector – Parenterals without an intended medical purpose is newly published, which provides guidance on some borderline topics. Although it is intended as a pharmaceutical/cosmetic borderline guideline, it covers injectables that can also be Annex XVI products and clarifies how such products qualify as regards enforcement and provides an overview and guidance for professionals, particularly those working in the cosmetic sector.Â
Swissmedic
The swissdamed User Guide UDI Devices Module V.2 has been published, featuring the addition of Chapter 8, “Discard UDIs”:
EU Commission
The EU Commission’s consultation process on the draft guidance and form for reporting serious incidents for high-risk AI systems under the AI Act is running until November 7th. The final guidance and form shall become applicable on August 2nd, 2026.
For medical devices and IVDs, this reporting would only apply to infringement of fundamental rights that significantly interfere with Charter-protected rights on a large scale, as all other serious incidents relative to AI-enabled medical device software would be routed through EU MDR/IVDR Vigilance.
Swissmedic
Swissmedic has published version 1.1 of the Information Sheet on Systems and Procedure Packs (SPP), featuring minor editorial changes and the addition of a notable example in Chapter 4.1: specimen collection kits are considered Procedure Packs.Â
Swissmedic’s position is misaligned with the note in chapter 2.6.1 of MDCG 2024-11 on the qualification of in-vitro diagnostic devices (IVD), which indicates that the qualification as either a Procedure Pack, according to the MDR, or an IVD Kit, according to the IVDR, should be based on the intended purpose of the whole product combination and that a Procedure Pack should not have an intended purpose that corresponds to Article 2(2) IVDR.
Moreover, Swissmedic’s position is also different from MDCG 2020-16 rev.4 on the classification of IVDs which considers kits intended for specimen collection by lay persons to be Class A IVDs, per rule 5(c).
This unfortunate position from Swissmedic may result in the diverging regulatory status of a same specimen collection kit in Switzerland and in the EU.
MedTech Europe
Medtech Europe has published a joint position paper on Digital label for authorised representative and importer, which urges the European Commission to allow details regarding the EU Authorised Representative and EU importer to be provided digitally, rather than solely on the physical label.
European Commission
The last amendment to the official list of Harmonised Standards (i.e. Implementing Decision (EU) 2025/2078 of 17 October 2025) only introduced standards relative to surgical clothing and drapes, medical face masks, and low temperature steam and formaldehyde sterilizers. It is however important to be aware that a new Consolidated List of HS under the EU MDR is now available.
Swissmedic
The information sheet for the cosmetic sector – Parenterals without an intended medical purpose is newly published, which provides guidance on some borderline topics. Although it is intended as a pharmaceutical/cosmetic borderline guideline, it covers injectables that can also be Annex XVI products and clarifies how such products qualify as regards enforcement and provides an overview and guidance for professionals, particularly those working in the cosmetic sector.Â
You will receive regular updates around regulation of medical devices.
